MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR.BEST MILCHZAHN; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case id : (b)(4).

Event Description

Bristle stuck in throat.Choked.Crying.Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a female patient who received gsk toothbrush (dr.(b)(6)) toothbrush (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr.(b)(6).On an unknown date, an unknown time after starting dr.(b)(6), the patient experienced foreign body in throat (serious criteria gsk medically significant), choking (serious criteria gsk medically significant), crying and product complaint.The action taken with dr.(b)(6) was unknown.On an unknown date, the outcome of the foreign body in throat, choking, crying and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, choking and crying to be related to dr.(b)(6).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Initial and qa result processed together.Initial additional information: adverse event details received by a consumer via call center representative on (b)(6) 2021, consumer stated that "i bought pii one of your toothbrushes.It is green and has a crocodile head as a protective cap.We were in the bathroom together and pii started choking and got tears in her eyes.She just said, "mom! hair!" and opened her mouth.Then i saw that a bristles had come loose and was stuck in her throat.I had to reach deep into her throat to remove the bristle.She wouldn't have made it on her own.It took some time and pii cried and choked.Really a terrible situation! has also worsened the situation "brushing teeth in the toddler" quite a bit, as you can perhaps imagine.Unfortunately, i have already disposed of packaging and no number to give you so that you can track the batch back.Nevertheless, i hope that it will be taken as a friendly hint to check/ reconsider the fastenings of the bristles, if this now is not the only case.We are "fans" of your brand and hope that you do not understand mail as "aggressive complaint mail".Follow-up information received from qa department on (b)(6) 2021: the product complaint reference id was (b)(4).And (b)(4).Complaint sample is not available, photographs of the complaint sample are not provided and toothbrush code is also not provided, so we are not able to check the retention sample production records of this batch.The product complaint stands inconclusive.Follow up information was received on (b)(6) 2021 from quality assurance (qa) department regarding complaint (b)(4)(issue number) for lot number unknown.The investigation reports concluded that, complaint stands unsubstantiated.Market complaint investigation was carried out in absence of market complaint sample; hence it's difficult to ascertain actual root cause for the observations made by the complainant.The availability of complaint sample could have helped us to evaluate and amp; establish the reasons for such complaint.As the complaint is being repeated, hence the further extended study is planned and same is under execution.Follow up information was received on (b)(6) 2021 via email , stating that," reporter received a letter and they were not in medical treatment or anything like that.It wasn't about a drug either.Reporters daughter swallowed on a loose bristle of a toothbrush.Reporter don't have the packaging of the toothbrush anymore and therefore not the batch number either.Only the brush is still here.".

• Brand Name: DR.BEST MILCHZAHN
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt, weid ; GM
• MDR Report Key: 12043187
• MDR Text Key: 267869135
• Report Number: 9615008-2021-00013
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other